More Than 15 Years Experience: Takeda Marks one Billion Treatment Courses of Gastric Ulcer Drug Pantoprazole

Zurich (ots/PRNewswire) -

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Takeda Pharmaceuticals International GmbH ("Takeda") today
announced that over one billion treatment courses of its
gastrointestinal product pantoprazole have been administered around
the world.[1] Initially launched in 1994 in Germany, pantoprazole, a
proton pump inhibitor (PPI) used to treat acid related diseases, is
available in more than 90 countries as a prescription treatment and
over-the-counter product.

Throughout the 17 years of experience with pantoprazole, ongoing
clinical trials have continued to deepen medical experience and
understanding. Most recently, in April 2012 the first clinical trial
evaluating tolerability, safety and efficacy of a PPI in patients
with chronic peptic complaints over fifteen years of drug
administration was published in the Journal Alimentary Pharmacology
and Therapeutics[2] by Prof. Brunner and co-workers from the
University Medical School Hannover.

The results of the analysis (n=142) demonstrated that daily
pantoprazole maintenance therapy for up to 15 years for severe
acid-peptic disease was effective and well tolerated. The results of
the analysis (n=142) reinforced that daily Pantoprazole maintenance
therapy for up to 15 years for severe acid-peptic disease is
effective and well tolerated. No safety concerns were identified. No
evidence of an enhanced risk for gastric carcinoma was observed in
assessments of laboratory and histological parameters. A major
strength of this study lies in the continuous collection of safety
data and, in particular, gastric histological data over the course of
15 years of daily treatment with pantoprazole. These results provide
reassuring evidence for the long-term safety of pantoprazole and
underline the benefits and the favourable efficacy and safety profile
of the product.

Prof. Brunner, Division of Gastroenterology and Hepatology at the
University Medical School Hannover, said "The patient outcomes after
15 years of treatment makes pantoprazole one of the best researched
PPIs in long-term treatment, reassuring the safety and efficacy
profile of this product."

Pantoprazole is a proton pump inhibitor used to treat the symptoms
of stomach and intestinal gastric ulcers, heartburn,
gastro-esophageal reflux disease (GERD) and other related
gastrointestinal diseases. Pantoprazole is marketed in more than 90
countries under a variety of brand names, including Pantozol(R),
Somac(R), Controloc(R), Pantoloc(R) and Zurcal(R). In the US, the
medicine is marketed by Takeda's partner, Pfizer Inc., under the
brand name Protonix(R).

In addition to pantoprazole, acquired through its merger with
Nycomed, Takeda has a long heritage of focusing on the issues that
affect patients living with upper gastrointestinal disorders through
the development of innovative treatments.

Other PPIs marketed by the Takeda Group include: Tecta(R), an
advanced magnesium-salt formulation of pantoprazole, Prevacid(R)
(lansoprazole), a well-known PPI in around 90 markets, and
Dexilant(R)(dexlansoprazole), the first PPI with a novel dual delayed
release technology.

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1. Periodic Safety Update Report (PSUR) No. 34 - pantoprazole,
October 2012

2. Brunner et al. Long-term, open-label trial: safety and efficacy
of continuous maintenance treatment with pantoprazole for up to 15
years in severe acid-peptic disease. Alimentary Pharmacology and
Therapeutics 2012; 36: 37-47

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in
Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company
Limited. As the largest pharmaceutical company in Japan and a leader
in the global industry, Takeda's mission is to strive toward better
health for patients worldwide through leading innovation in medicine.
It has a commercial presence in around 70 countries, with particular
strength in Asia, North America, Europe and fast-growing emerging
markets including Latin America, Russia-CIS and China. Takeda is
ranked 12th by global Rx sales, 14th in the BRIC countries and 18th
in Europe. Areas of focus include cardiovascular and metabolic
diseases, immunology and respiratory diseases, oncology and central
nervous system diseases, among others. Through the integration of
Millennium Pharmaceuticals and Nycomed, Takeda has been transforming
itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its
corporate website, http://www.takeda.com.

This press release has been issued by Takeda Pharmaceuticals
International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon,
Zurich, Switzerland.

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